Cabenuva Injection Tracking in CHORUS

Epividian37 enrolled

Overview

This is a cluster randomized trial in which clinics will be randomized to the intervention or the control arm. The purpose of this study is to assess if receiving alerts can help providers manage the scheduling of monthly cabotegravir + rilpivirine long-acting injections for the treatment of HIV.

A novel long-acting HIV antiretroviral therapy has recently been approved by the FDA: cabotegravir and rilpivirine delivered through intramuscular injection. These injections should be administered monthly, on the same day of the month as the initiation injections, up to 7 days before or after the date of the scheduled monthly injection visit. This is a cluster randomized trial in which clinics will be randomized to the intervention or the control arm. Providers in the intervention group will receive alerts to remind them when patients are due for their injections, or if they missed their treatment window. Providers in the control group will not receive alerts and will manage injections as per their clinic's standard process. Surveys will be administered to understand the utility of the alerts for the management of these injections.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS AppOTHER

The CHORUS App has been developed as a tool for clinicians to easily visualize important patient information from their smart phones. Relevant information is electronically distributed and placed within the corresponding module in the CHORUS HCP mobile app for iOS and Android.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria (patients): * As per label, routine clinical care Inclusion Criteria (clinics): * AIDS Healthcare Foundation (AHF) Clinic * HIV primary care clinic * Minimum of 100 people living with HIV in care with a viral load \<50 copies/mL at the time of randomization (satellites will be included in the count of their parent clinic).

Locations (1)

AIDS Healthcare Foundation

Los Angeles, California, United States

Outcomes

Primary Outcomes

Adherence to treatment-window

Patient returns for their injections +/- 7 days from target date

Time frame: 9 months

Acceptability and usefulness of the intervention

Survey to assess the implementation of the Cabenuva Scheduling Alerts in the Retention \& Huddle modules of the CHORUS App.

Time frame: Month 1

Acceptability and usefulness of the intervention

Survey to assess the implementation of the Cabenuva Scheduling Alerts in the Retention \& Huddle modules of the CHORUS App.

Time frame: Month 9

Secondary Outcomes

Number of CAB+RPV LA patients managed through the app

Reach

Time frame: 9 months

Number of clinics that use the App for the management of CAB+RPV LA patients

Adoption

Time frame: 9 month

Data from ClinicalTrials.gov

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